April 15, 2020: “Humanigen, Inc., (HGEN) (“Humanigen”), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the company’s proprietary Humaneered® anti-human GM-CSF monoclonal antibody, announced that FDA has given permission to commence a Phase III study of lenzilumab in patients with COVID-19.
Humanigen plans to enroll patients in a multicenter, randomized, placebo-controlled, double-blinded clinical trial with lenzilumab for the prevention of respiratory failure and/or death in hospitalized patients with pneumonia associated with SARS-CoV-2 infection in COVID-19 patients.
“We are working with some of the top centers and clinicians in the US, alongside our contract research organization partner, CTI, to bring lenzilumab rapidly through this clinical study which, if successful, may reduce serious and potentially fatal outcomes in patients hospitalized with COVID-19 and at high risk of progression,” said Dr. Cameron Durrant, chief executive officer of Humanigen.
“We are pleased with the unprecedented speed with which this program has moved from concept to active trial,” remarked Tim Schroeder, founder and CEO of CTI. “It is a demonstration of both the commitment of the CTI and Humanigen teams and an exceptional level of collaboration between us and our counterparts at the FDA. Everyone is working extraordinarily hard to help bring treatments to patients, and we are proud to be a part of that effort.”
Dr. Durrant continued, “Lenzilumab has demonstrated an excellent safety and tolerability profile in other disease settings, including severe asthma. As the only company that has been working on prevention of cytokine storm through GM-CSF neutralization for nearly three years, we have published extensively in this field and filed extensive IP. We plan to bring this experience to the COVID-19 setting and recruit patients into this Phase III study as quickly as possible.”
COVID-19 is an infectious disease caused by SARS-CoV-2. COVID-19 has become a global pandemic, with almost 2 million confirmed cases and over 125,000 deaths reported to date. Patients with severe cases of COVID-19 experience severe viral pneumonia that can progress to acute respiratory distress syndrome (ARDS), respiratory failure and death.” https://www.humanigen.com/press/FDA-Approves-Initiation-of-Humanigen%E2%80%99s-Phase-III-Study-of-Lenzilumab-in-COVID-19-Patients
